MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. POWER SUPPLY, ELEC. DERMATOME

Model Number N/A

Device Problems Unintended Power Up (1162); Sparking (2595); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/07/2022

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Once an evaluation of this device is completed, a follow-up/final report will be submitted.Telephone number: (b)(6).

Event Description

When the device was plugged in there was a loud buzzing noise, a pop and then the machine was no longer working.There was a single spark at the same time as the audible pop but no smoke.Did not occur during surgery and there was no patient involvement.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(6).This medwatch is being filed to relay additional information.The following sections have been updated: b4, d4, d9, g3, g6, h2, h3, h4, h6, h8, h10.Review of the most recent repair record could not be completed because the device was not returned for evaluation and repair.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event cannot be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional event information.

• Brand Name: POWER SUPPLY, ELEC. DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14840696
• MDR Text Key: 302572471
• Report Number: 0001526350-2022-00616
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: LA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00882100600
• Device Lot Number: 30498200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/1995
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1